MAUDE Adverse Event Report: COAPTECH, INC. PUMA-G SYSTEM; FEEDING TUBE PLACEMENT AID

Model Number	001021X
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A pre-procedure ultrasound check (by phased array transducer) showed a 4cm tissue depth for the gastrostomy.The initial steps of the percutaneous ultrasound gastrostomy (pug) procedure were completed to achieve coupling between the percutaneous guidewire (pgw) and internal balloon catheter (ibc) and to advance the coupled pgw and ibc out of the mouth.The pgw was cut to remove the pigtail end and then fed into the g-tube, but halted after resistance was encountered pulling the guidewire out of the mouth after feeding about 10-15cm of guidewire into the g-tube.The guidewire was removed from the g-tube at this point to troubleshoot the encountered resistance.At the abdominal end, the guidewire was able to advance easily but when pulled back, resistance was met at a certain point of slack removal.A glidescope was used to view the guidewire in the mouth and upper throat, which showed no apparent issues.The guidewire was removed from the abdominal end using clamps for grip in a safe abort, at which point, two kinked areas of the guidewire were observed (see figure 1 below).No further complications or clinical effects were reported as confirmed by a post-procedural x-ray, no bleeding, normal gastric suctioning, and no change in oral secretions.No issues were reported in the weeks following the case as well.While this case was determined to not result in a serious injury, the device malfunction observed in the case resulted in initial resistance removing the guidewire.If clinical circumstances were different and the malfunction were to recur, there is a possibility that the procedure would not be able to be aborted without further medical interventions.Therefore, this event is reportable due to the possibility to cause or contribute to a serious injury if the malfunction were to recur.

• Brand Name: PUMA-G SYSTEM
• Common Device Name: FEEDING TUBE PLACEMENT AID
• Manufacturer (Section D): COAPTECH, INC.; 101 w dickman st, suite 700; baltimore MD 21230
• Manufacturer (Section G): COAPTECH, INC.; 101 w dickman st, suite 700; baltimore MD 21230
• Manufacturer Contact: michelle garner ; 101 w dickman st, suite 700; baltimore, MD 21230 ; 4435746934
• MDR Report Key: 18241693
• Report Number: 3015177732-2023-00003
• Device Sequence Number: 17784861
• Product Code: KGC
• UDI-Device Identifier: 00850026037043
• UDI-Public: (01)00850026037043(17)240301(10)2023100901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 001021X
• Device Lot Number: 2023100901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GASTROSTOMY TUBE.
• Patient Sex: Female